The present invention is directed to refractive correction devices including a phakic intraocular lens and/or intracorneal ring. Further, the present invention is directed to the combination of a phakic intraocular lens and intracorneal ring. The intracorneal ring according to the present invention is preferably adjustable in size, shape and/or configuration. The phakic intraocular lens and intracorneal ring according to the present invention are preferably biocompatible. The present invention is also directed to methods of refractive correction of the eye.
The refractive correction of the human eye is a rapidly developing market in the United States and the world. Many patients are interest in getting rid of their conventional eye glasses and/or contact lenses to improve their personal looks and benefit from the numerous conveniences from these refractive correction procedures over wearing conventional eye glasses and/or contact lenses.
The current methods for refractive correction of the eye include LASIK surgery, a procedure for reshaping the cornea with a laser underneath a flap of the cornea, implantation of a phakic intraocular lens (e.g. Implantable Contact Lens (ICL), a phakic refractive lens (prk) manufactured by Staar Surgical AG of Switzerland), implantation of an intracorneal ring (icr) into the stroma of the eye, and other surgical procedures including prk and rk.
Staar Surgical AG of Switzerland has been researching and developing a phakic refractive lens (prl) for implantation in the posterior chamber and located between the iris and natural crystalline lens. The Implantable Contact Lens(copyright) brand phakic corrective lens is currently capable of correcting +10 to 18 diopters and xe2x88x9210 to 18 diopters correction. There exists a number of parameters that must be considered for preparing the proper size and prescription of the Implantable Contact Lens(copyright) to achieve a high level of visual acuity once implanted in a patient""s eye.
The present invention proposes making a substantial correction of vision with the Implantable Contact Lens brand phakic corrective lens, and then possibly following up with one or more additional refractive correction procedures to fine tune the patient""s eye for high visual acuity. Specifically, it is possible to over correct or under correct a patients eye with an Implantable Contact Lens brand phakic refractive corrective lens during an operation. Further, due to the effects of healing and/or aging of the patient""s eye, it may become necessary to provide an additional subsequent procedure to fine tune a minor refractive correction of the patient""s eye to achieve a high level of visual acuity. Thus, after implantation of an Implantable Contact Lens brand phakic refractive lens the patient""s eye may be treated immediately or later in time with a subsequent procedure such as LASIK and/or implantation of an intracorneal ring.
An object of the present invention is to provide a refractive correction device in the eye.
A second object of the present invention is to provide multiple refractive correction devices in the eye.
A third object of the present invention is to provide a refractive correction device in combination with a refractive correction procedure in the eye.
A fourth object of the present invention is to provide the combination of a phakic refractive lens and an adjustable intracorneal ring.
A fifth object of the present invention is to provide an adjustable intracorneal ring arranged so that the size, shape, and/or configuration can be changed prior to insertion in the eye.
A sixth object of the present invention is to provide an adjustable intracorneal ring arranged so that the size, shape and/or configuration of the adjustable intracorneal ring can be adjusted after being implanted in the eye.
A seventh object of the present invention is to provide an adjustable intracorneal ring arranged so that the size, shape and/or configuration of the intracorneal ring can be changed after being implanted in the eye by electromagnetic waves such as light, laser, electromagnetic, electromagnestrictive, etc.
An eighth object of the present invention is to provide a method of refractive correction of an eye.
A ninth object of the present invention is to provide a method of refractive correction of the eye including the step of adjusting the size, shape, and/or configuration of an intracorneal ring after being implanted in the eye.
A tenth object of the present invention is to provide a method of refractive correction of an eye including the steps of providing at least two refractive correction devices and/or refractive correction procedures of the eye.
The present invention is to provide for the refractive correction of an eye. The present invention can include refractive correction devices and/or refractive correction procedures. Preferably, the present invention is directed to refractive correction of the eyes with multiple refractive correction devices and/or refractive correction procedures.
A preferred embodiment of the present invention includes providing a phakic refractive lens (e.g. Implantable Contact Lens brand phakic refractive lens) in combination with an intracorneal ring in the eye. Preferably, the refractive correction lens is first implanted and then the intracorneal ring is implanted immediately thereafter. However, the intracorneal ring can be implanted minutes, hours, days, or weeks later. The phakic refractive lens can be a hard lens (e.g. made of polymethyl methacrylate PMMA) or more preferably a deformable phakic refractive lens (e.g. made of a resilient biocompatible material such as a collagen-based polymer (e.g. Collamer), silicone, hydrogel, or other suitable biocompatible polymer or plastic material). The phakic corrective lens can be for correction of power only and/or can be for the correction of power and astigmatism. For example, the phakic correction lens can be a toric phakic correction lens (e.g. toric implantable contact lens and/or prism phakic correction lens). The intracorneal ring can be a single ring, one or more segments of a ring, a composite ring made of different materials or layers of materials, or an adjustable intracorneal ring. A preferred combination is an Implantable Contact Lens brand phakic refractive lens with an adjustable intracorneal ring.
Another preferred embodiment of the present invention is providing a phakic refractive lens with a intracorneal refractive lens ring. The intracorneal refractive lens ring is an intracorneal ring configured to provide refractive properties with or without lens power correction ability. The intracorneal refractive lens ring can be configured to focus light to provide near sight visual acuity, for example, after LASIK surgery which typically decreases near visual acuity of the patient. The bulk opr displace volume of the intracorneal refractive lens ring dictates the extent to which this device will also provide lens power correction of the cornea of the patient. For example, the device can be made very thin so as to have no power correction effect, or it can be increased in thickness to provide some lens power correction. The intracorneal refractive lens ring can be in the configuration of a one-piece ring or can be one or more segments of a ring. The device, for example, can be implanted by first tunneling a circular path between layers of the stroma with a surgical instrument (e.g. treefind), and then the ring or segments can be implanted in the circular tunnel.
A further preferred embodiment of the present invention is to provide the combination of a LASIK correction procedure with an intracorneal ring with or without refractive lens properties. Specifically, the intracorneal ring can be configured to provide bulk in the stroma of the eye to provide lens power correction. Alternatively, the intracorneal ring can be an intracorneal refractive lens ring configured to change the focal point of a portion of the eye with or without bulk to optionally change the lens power of the eye.
An even further preferred embodiment of the present invention is to provide an adjustable intracorneal ring (AICR). The adjustable intracorneal ring can be configured so that the size, shape and/or configuration of the intracorneal ring can be changed after manufacture, but prior to final prescription, adjusted after prescription, adjusted prior to implantation, and/or adjusted after implantation (e.g. in situ). The adjustable intracorneal ring can be configured to be adjusted by mechanical, hydraulic and/or pneumatic means. Alternatively, or in addition, the adjustable intracorneal ring can be adjusted by electromagnetic waves, for example, heat, UV, laser, electromagnetic, electromagnetostrictive, X-ray, or other suitable wavelength of electromagnetic radiation. The use of a laser is particularly preferable for adjustment of the adjustable intracorneal ring once implanted in the eye, since the laser can be adjusted to pinpoint accuracy.
The adjustable intracorneal ring according to the present invention is configured to be adjusted in size, shape and/or configuration. The adjustable intracorneal ring can be made of material that will change in size, shape, and/or configuration when a mechanical, hydraulic, pneumatic and/or electromagnetic radiation is applied to the adjustable intracorneal ring. Alternatively, or in addition, the adjustable intracorneal ring can be configured by design to be adjustable when a mechanical force, hydraulic force, pneumatic force and/or electromagnetic radiation is applied to the adjustable intracorneal ring. For example, the adjustable intracorneal ring can be designed with varying thicknesses or other dimensions, one or more holes, passageways, grooves, edges, layers, cells, matrixes, strata, grain, bubbles, voids, indentations, surface roughening, surface finish, or other physical parameters can be designed to allow the ring to be permanently and/or non-permanently adjusted. The adjustable intracorneal ring according to the present invention can be designed and/or configured to be reversibly adjusted. In another preferred embodiment of the adjustable intracorneal ring according to the present invention, the size of the adjustable intracorneal ring can be increased or decreased. Further, in another embodiment, the direction of movement of portions of the adjustable intracorneal ring can be moved in various directions.
The adjustable intracorneal ring according to the present invention can be adjustable in thickness to vary the amount of bulk, and thus the amount of power correction of the eye. Alternatively, or in addition, the overall shape of the adjustable intracorneal ring can be adjusted to vary the visual axis to adjust for astigmatism of the vision of the particular eye. For example, the ring can be made oval in shape along a particular visual axis to compensate for astigmatism. In addition, an adjustable intracorneal refractive lens ring can be adjustable to change the focal length of a portion of the light entering the eye to change the near visual acuity.
The intracorneal ring according to the present invention is preferably made of a clear translucent material such as polymethylmethacrylate (PMMA), silicone, hydrogel, collagen-based polymer (e.g. Collamer), and other suitable polymers and plastics. Alternatively, the intracorneal ring according to the present invention can be colored. For example, the intracorneal ring can be colored to match the color of the patient""s iris. Further, the intracorneal ring according to the present invention can be colored in a specific pattern to match the striations and color of the natural iris of the patients. In addition, the intracorneal ring according to the present invention can be specifically textured (e.g. provided with radial groove striations) in addition to a coloring pattern to closely match with the color pattern and texture pattern of the natural iris of the patient""s eye. A computer method of matching the color pattern and texturing pattern of the patient""s eye at the exact location where the implant will be placed in the cornea can be developed to carefully match a prescription of the intracorneal ring. Alternatively, the intracorneal ring can be configured to reflect the color pattern and texturing pattern of the patient""s natural cornea at a portion adjacent to the location of the intracorneal ring. For example, the intracorneal ring can be tinted and/or provided with at least one reflective surfaces to reflect the coloring pattern and texturing pattern of the patient""s eye to a person looking closely at a patient""s eye with the implants.
A preferred adjustable intracorneal ring according to the present invention is made from a material having some water content, most preferably a high water content. For example, hydrogels and/or Collamer material can potentially be adjusted in thickness and/or shape and/or configuration by being exposed to a laser. For example, the laser can potentially change the water content and/or confirmation of the polymer strands making up the polymer material. Thus, the size, shape and/or configuration at local points or overall can be changed by treatment with a laser prior to implantation or after implantation (i.e. insitu). For example, an intracorneal ring or ring segments can be adjusted in size, shape and/or configuration to adjust the lens power and/or lens axis to adjust for astigmatism by exposing the implanted Collamer intracorneal ring with a laser insitu to make final corrections of visual power and acuity.